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Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). (COMBI-AD)

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dabrafenib

Trametinib

Placebos

About this trial

This is an interventional treatment trial for Melanoma focused on measuring MEK inhibitor, trametinib, Oncology, adjuvant melanoma, dabrafenib, dabrafenib and trametinib combination therapy, BRAF mutation-positive melanoma, BRAF inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.
Surgically rendered free of disease no more than 12 weeks before randomization.
Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Adequate hematologic, hepatic, renal and cardiac function.

Key Exclusion Criteria:

Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases.
Evidence of distant metastatic disease.
Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed.
History of another malignancy or concurrent malignancy including prior malignant melanoma. Exceptions to this include: Patients who have been disease-free for 5 years or patients with a history completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, or other malignancies for which the patient has been disease free for > 5 years.
History or current evidence of cardiovascular risk.
History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dabrafenib and trametinib

Dabrafenib and trametinib placebos

Arm Description

Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.

Subjects received matching placebos orally for 12 months

Outcomes

Primary Outcome Measures

Relapse-free Survival (RFS)

Recurrence-free survival was defined as the time from randomization to disease recurrence (local recurrence, distant recurrence, second primary melanoma), or death from any cause.

Secondary Outcome Measures

Overall Survival

Overall survival (OS) of dabrafenib and trametinib as a combination therapy versus placebo

Distant Metastasis-free Survival

Distant metastasis-free survival (DMFS) of dabrafenib and trametinib as a combination therapy versus placebo. In the DMFS analysis, the first occurrence of distant metastasis or death (if it occurred before documented recurrence) was counted as an event.

Freedom From Relapse

Freedom from relapse (FFR) of dabrafenib and trametinib as a combination therapy versus placebo. In the FFR analysis, local or distant recurrence or a new primary melanoma were counted as events, and patients who died of causes other than melanoma or treatment-related toxicity were censored.

Full Information

NCT ID

NCT01682083

First Posted

September 6, 2012

Last Updated

August 16, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01682083

Brief Title

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

Acronym

COMBI-AD

Official Title

COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 8, 2013 (Actual)

Primary Completion Date

June 30, 2017 (Actual)

Study Completion Date

July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

Detailed Description

This was a two-arm, randomized, double-blind, multi-center, international phase III study of dabrafenib in combination with trametinib versus two matching placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]). None of the patients had undergone previous systemic anticancer treatment or radiotherapy for melanoma. All the patients had undergone completion lymphadenectomy with no clinical or radiographic evidence of residual regional node disease within 12 weeks before randomization, had recovered from definitive surgery, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. BRAF V600 mutation status was confirmed in primary-tumor or lymph-node tissue by a central reference laboratory. All the patients provided written informed consent. The primary end point was recurrence-free survival, Overall survival, as the key secondary end point, was to be tested in a hierarchical manner only if the primary end point met the criteria for significance. The overall survival analysis used a preplanned three-look Lan-DeMets group sequential design with an O'Brien-Fleming-type boundary, which was used to determine the significance threshold for the first interim overall survival analysis (two-sided P=0.000019). Disease assessments included clinical examination and imaging by means of computed tomography, magnetic resonance imaging, or both.) Imaging was performed every 3 months during the first 24 months, then every 6 months until disease recurrence or the completion of the trial. Follow-up for survival began after recurrence and continued through the end of the trial. Adverse events and laboratory values were assessed at screening, on the date of randomization, at least once per month through month 12, and at every visit for disease-recurrence assessment after month 12. Adverse events and laboratory values were graded according to the Common Terminology Criteria for Adverse Events, version 4.0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

MEK inhibitor, trametinib, Oncology, adjuvant melanoma, dabrafenib, dabrafenib and trametinib combination therapy, BRAF mutation-positive melanoma, BRAF inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

870 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dabrafenib and trametinib

Arm Type

Experimental

Arm Description

Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.

Arm Title

Dabrafenib and trametinib placebos

Arm Type

Placebo Comparator

Arm Description

Subjects received matching placebos orally for 12 months

Intervention Type

Drug

Intervention Name(s)

Dabrafenib

Other Intervention Name(s)

GSK2118436

Intervention Description

Each capsule contained 50 mg or 75 mg of free base (present as the mesylate salt)

Intervention Type

Drug

Intervention Name(s)

Trametinib

Other Intervention Name(s)

GSK1120212

Intervention Description

Each tablet contained 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

The placebo capsules and tablets contained the same inactive ingredients and film coatings as the dabrafenib and trametinib study treatment

Primary Outcome Measure Information:

Title

Relapse-free Survival (RFS)

Description

Recurrence-free survival was defined as the time from randomization to disease recurrence (local recurrence, distant recurrence, second primary melanoma), or death from any cause.

Time Frame

Approximately 3.5 years

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival (OS) of dabrafenib and trametinib as a combination therapy versus placebo

Time Frame

approximately 3.5 years

Title

Distant Metastasis-free Survival

Description

Time Frame

approximately 3.5 years

Title

Freedom From Relapse

Description

Time Frame

approximately 3.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible. Surgically rendered free of disease no more than 12 weeks before randomization. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains). Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. Adequate hematologic, hepatic, renal and cardiac function. Key Exclusion Criteria: Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases. Evidence of distant metastatic disease. Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed. History of another malignancy or concurrent malignancy including prior malignant melanoma. Exceptions to this include: Patients who have been disease-free for 5 years or patients with a history completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, or other malignancies for which the patient has been disease free for > 5 years. History or current evidence of cardiovascular risk. History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35243

Country

United States

Facility Name

Novartis Investigative Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novartis Investigative Site

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Novartis Investigative Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Novartis Investigative Site

City

Stuart

State/Province

Florida

ZIP/Postal Code

34994

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30341

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Novartis Investigative Site

City

Lutherville-Timonium

State/Province

Maryland

ZIP/Postal Code

21093

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Novartis Investigative Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48019

Country

United States

Facility Name

Novartis Investigative Site

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-5536

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Novartis Investigative Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1050AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Viedma

State/Province

Río Negro

ZIP/Postal Code

R8500ACE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1025ABH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1121ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Gateshead

State/Province

New South Wales

ZIP/Postal Code

2290

Country

Australia

Facility Name

Novartis Investigative Site

City

North Sydney

State/Province

New South Wales

ZIP/Postal Code

2060

Country

Australia

Facility Name

Novartis Investigative Site

City

Tweed Heads

State/Province

New South Wales

ZIP/Postal Code

2485

Country

Australia

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

Greenslopes

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Facility Name

Novartis Investigative Site

City

Milton

State/Province

Queensland

ZIP/Postal Code

4064

Country

Australia

Facility Name

Novartis Investigative Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novartis Investigative Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Novartis Investigative Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

A-5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Wels

ZIP/Postal Code

A-4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A-1030

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A-1220

Country

Austria

Facility Name

Novartis Investigative Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Novartis Investigative Site

City

Goiania

State/Province

Goiás

ZIP/Postal Code

74605-030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

Novartis Investigative Site

City

Ijui

State/Province

Rio Grande Do Sul

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio De Janeiro

ZIP/Postal Code

22 260-020

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

ZIP/Postal Code

01323-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

Novartis Investigative Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1S6

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Novartis Investigative Site

City

Zlin

ZIP/Postal Code

76275

Country

Czechia

Facility Name

Novartis Investigative Site

City

Arhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Novartis Investigative Site

City

Odense

ZIP/Postal Code

5000 C

Country

Denmark

Facility Name

Novartis Investigative Site

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Novartis Investigative Site

City

Boulogne-Billancourt

ZIP/Postal Code

92100

Country

France

Facility Name

Novartis Investigative Site

City

Brest cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Marseille cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75006

Country

France

Facility Name

Novartis Investigative Site

City

Pierre-Benite cedex

ZIP/Postal Code

69495

Country

France

Facility Name

Novartis Investigative Site

City

Reims Cedex

ZIP/Postal Code

51092

Country

France

Facility Name

Novartis Investigative Site

City

Rennes Cedex

ZIP/Postal Code

35042

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Tours Cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

Novartis Investigative Site

City

Villejuif cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Novartis Investigative Site

City

Freiburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

79104

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Heilbronn

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

74078

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68167

Country

Germany

Facility Name

Novartis Investigative Site

City

Tuebingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80337

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80804

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

State/Province

Bayern

ZIP/Postal Code

90419

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Darmstadt

State/Province

Hessen

ZIP/Postal Code

64297

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

State/Province

Hessen

ZIP/Postal Code

34125

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

State/Province

Hessen

ZIP/Postal Code

35043

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

State/Province

Hessen

ZIP/Postal Code

65199

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19049

Country

Germany

Facility Name

Novartis Investigative Site

City

Buxtehude

State/Province

Niedersachsen

ZIP/Postal Code

21614

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Homburg

State/Province

Saarland

ZIP/Postal Code

66421

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Quedlinburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06484

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

State/Province

Thueringen

ZIP/Postal Code

99089

Country

Germany

Facility Name

Novartis Investigative Site

City

Gera

State/Province

Thueringen

ZIP/Postal Code

07548

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10249

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13585

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

54622

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

564 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00167

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

Lombardia

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20141

Country

Italy

Facility Name

Novartis Investigative Site

City

Candiolo

State/Province

Piemonte

ZIP/Postal Code

10060

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Auckland

ZIP/Postal Code

0622

Country

New Zealand

Facility Name

Novartis Investigative Site

City

Alesund

ZIP/Postal Code

6026

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0310

Country

Norway

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-215

Country

Poland

Facility Name

Novartis Investigative Site

City

Konin

ZIP/Postal Code

62-500

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04-125

Country

Poland

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

143423

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

191104

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Volgograd

ZIP/Postal Code

400138

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Cartagena

ZIP/Postal Code

30202

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas De Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Goteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W1G 6AD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Preston

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

34225229

Citation

Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

Results Reference

derived

PubMed Identifier

32877599

Citation

Dummer R, Hauschild A, Santinami M, Atkinson V, Mandala M, Kirkwood JM, Chiarion Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Gasal E, Tan M, Long GV, Schadendorf D. Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma. N Engl J Med. 2020 Sep 17;383(12):1139-1148. doi: 10.1056/NEJMoa2005493. Epub 2020 Sep 2.

Results Reference

derived

PubMed Identifier

32007138

Citation

Dummer R, Brase JC, Garrett J, Campbell CD, Gasal E, Squires M, Gusenleitner D, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Flaherty K, Larkin J, Robert C, Kefford R, Kirkwood JM, Hauschild A, Schadendorf D, Long GV. Adjuvant dabrafenib plus trametinib versus placebo in patients with resected, BRAFV600-mutant, stage III melanoma (COMBI-AD): exploratory biomarker analyses from a randomised, phase 3 trial. Lancet Oncol. 2020 Mar;21(3):358-372. doi: 10.1016/S1470-2045(20)30062-0. Epub 2020 Jan 30.

Results Reference

derived

PubMed Identifier

30928620

Citation

Schadendorf D, Hauschild A, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Lesimple T, Plummer R, Schachter J, Dasgupta K, Manson S, Koruth R, Mookerjee B, Kefford R, Dummer R, Kirkwood JM, Long GV. Patient-reported outcomes in patients with resected, high-risk melanoma with BRAFV600E or BRAFV600K mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 May;20(5):701-710. doi: 10.1016/S1470-2045(18)30940-9. Epub 2019 Mar 27.

Results Reference

derived

PubMed Identifier

30343620

Citation

Hauschild A, Dummer R, Schadendorf D, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Haas T, Shilkrut M, Gasal E, Kefford R, Kirkwood JM, Long GV. Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma. J Clin Oncol. 2018 Dec 10;36(35):3441-3449. doi: 10.1200/JCO.18.01219. Epub 2018 Oct 22.

Results Reference

derived

PubMed Identifier

28891408

Citation

Long GV, Hauschild A, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma. N Engl J Med. 2017 Nov 9;377(19):1813-1823. doi: 10.1056/NEJMoa1708539. Epub 2017 Sep 10.

Results Reference

derived

Learn more about this trial

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

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Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). (COMBI-AD)

Melanoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial